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PCT 



WORLD INTELLECTUAL PROPERTY ORGANIZATION 
International Bureau 




INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) 



(51) International Patent Classification 6 : 

BOIL 11/00, G01N 33/487, BOIL 9/DO 



Al 



(11) International Publication Number: WO 97/29847 

(43) Internationa] Publication Date: 21 August 1997 (21.08.97) 



(21) International Application Number: PCT/US97/02166 

(22) International Filing Date: 1 1 February 1997 (1 1.02.97) 



(30) Priority Data: 

08/600,449 



1 3 February 1996 (1 3.02.96) US 



(71) Applicant: SELFCARE, INC. [US/USJ; 200 Prospect Street, 

Waltham, MA 02154 (US). 

(72) Inventors: MCALEER, Jerome, F.; 52 Nobles Close, Wantage 

OXI2 0NR (GB). MOERMAN, Piet, H., C; Grimbergses- 
teenweg 5, B-1980 Zemst (BE). SIU, Ta; 21 Park Street, 
Alhambra, CA 91801 (US). 

(74) Agents: LARSON, Marina, T. et al.; Oppedahl & Larson, Suite 
309, 1992 Commerce Street, Yorktown Heights, NY 10598- 
4412 (US). 



(81) Designated States: AL, AM, AT, AU f AZ, BA, BB, BG, BR, 
BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GE, 
HU, IL, IS. JP. KE, KG. KP, KR, KZ. LC. LK, LR, LS, 
LT, LU t LV, MD, MG. MK, MN, MW, MX, NO, NZ. PL. 
PT, RO, RU, SD, SE, SG f SI. SK, TJ, TM, TR, IT, UA, 
UG, UZ, VN, ARIPO patent (KE, LS, MW, SD, SZ, UG), 
Eurasian patent (AM, AZ, BY, KG. KZ, MD, RU, TJ, TM), 
European patent (AT, BE, CH, DE, DK, ES, FI, FR, GB, 
GR, IE, IT, LU, MC, NL, PT, SE), OAPI patent (BF, BJ, 
CF, CG, CI, CM, GA, GN, ML, MR, NE, SN, TD, TG). 



Published 

With international search report. 

Before the expiration of the time limit for amending the 
claims and to be republished in the event of the receipt of 
amendments. 



(54) Title: IMPROVED GLUCOSE MONITOR AND TEST STRIP CONTAINERS FOR USE IN SAME 



12 



6 1 




(57) Abstract 

e test meter of the type which receives a disposable test strip and a sample of bodily fluid from a patient and performs an electrochemical 
analysis of the amount of an analyte such as glucose in the sample includes a receptacle (7) for receiving a container (10) in which disposable 
test strips are provided, and a mechanism for reading information about the disposable test strips mat is affixed to the container. For example, 
calibration values can be applied to the container in the form of a machine readable bar-code, a magnetic stripe, a memory chip or as a 
resonant wire loop. By automatically obtaining calibration values from the container in which the strips are provided, the chances of using 
the wrong calibration information are greatly reduced. The container may also contain information readable by the meter including the 
expiration date, and the number of test strips in the container. 



FOR THE PURPOSES OF INFORMATION ONLY 

, Codes used to identify States party to the PCT on the front pages of pamphlets publishing international 
applications under the PCT. 



AM 


Armenia 


GB 


United Kingdom 


AT 


Austria 


GE 


Georgia 


AU 


Australia 


GN 


Guinea 


BB 


Barbados 


CR 


Greece 


BE 


Belgium 


HU 


Hungary 
Ii eland 


BF 


Burkina Paso 


IE 


BG 


Bulgaria 


IT 


Italy 


Bl 


Benin 


JF 


Japan 


BR 


Brazil 


KB 


Kenya 


BY 


Belarus 


KG 


Kyrgystan 


CA 




KF 


Democratic Peopled 


CF 


Central African Republic 




of Korea 


CG 


Congo 


KR 


Republic of Korea 


CH 


Switzerland 


KZ 


Kazakhstan 


a 


Cote dlvofo 


U 


1 JcdattCttCall 


CM 


Cameroon 


IX 


Sri Lanka 


CN 


China 


LR 


Liberia 


CS 


Ciechoatovtkta 


LT 




CZ 


Cxetii Republic 


LU 


Luxembourg 


DC 


Germany 


LV 


Latvia 


DK 


Denmark 


MC 


1 Inn . ■ ■ 

Monaco 


EE 


Estonia 


MD 


Republic of Moldova 
Madagascar 


ES 


Spain 


MG 


n 


Finland 


ML 


Man* 


FR 


France 


MN 


Mongolia 


CA 


Gabon 


MR 


Mauritania 



MW 


Malawi 


MX 


Mexico 


NS 


Niger 


ML 


Netherlands 


NO 


Norway 


NZ 


New Zealand 


PL 


Poland 


FT 


Portugal 


RO 




RU 


Russian Federation 


SD 


Sudan 


SE 


Swedes 


SG 


Singapore 


« 


Slovenia 


SK 


Slovakia 


SN 


Senegal 


SZ 


Swaziland 


TD 


Chad 


TG 


Togo 


TJ 


Tajikistan 


TT 


Trinidad and Tobago 


UA 


Ukraine 


UG 


Uganda 


US 


United State* of America 


uz 


Uzbekistan 


VN 


Viet Nam 



WO 97/29847 PCT/US97/02166 

- 1 - 

IMPROVED GLUCOSE MONITOR AND TEST STRIP 
CONTAINERS FOR USE IN SAME 

DESCRIPTION 
BACKGROUND OF THE INVENT TON 

This application relates to an improved type of 
glucose monitor which is automatically calibrated for the 
particular test strips being used, and to test strip 
5 containers for use in such a monitor. 

Glucose monitoring is a fact of everyday life 
for diabetic individuals, and the accuracy of such 
monitoring can literally mean the difference between life 
and death. To accommodate a normal life style to the 

10 need for frequent monitoring of glucose levels, a number 
of glucose meters are now available which permit the 
individual to test the glucose level in a small amount of 
blood. The success of these devices, however, depends on 
the ability of the user to obtain a correct reading. 

15 Many of the meter designs currently available 

make use of a disposable test strip which in combination 
with the meter measures the amount of glucose in the 
blood sample electrochemically . Lot-to-lot variation 
during the manufacture of test strips requires that the 

20 user calibrate the system for each batch of strips. This 
is normally accomplished by inserting a calibration 
strip, provided with each package of test strips, into 
the meter. This process introduces the possibility of 
error as a result of failure of the user to perform the 

25 calibration procedures in the correct manner or at the 

correct times. In particular, errors in calibration can 
occur if a user opens a new package of test strips and 
fails to perform the calibration step or if a, user has 
several packages of test strips open and confuses the 

30 calibration strips between the packages. 

It is an object of the present invention to 
provide a meter, and particularly a glucose meter, which 
obviates the need for user initiated calibration. 



W0 97/29S47 



PCT/US97/02166 



- 2 



It is a further object of the invention to 
provide a meter, and particularly a glucose meter, which 
reduces the likelihood of a test strip being used with 
the incorrect meter calibration. 

5 

SUMMARY OF THE INvwrTfifl 

These and other objects of the invention are 
provided by a test meter of the type which receives a 
disposable test strip and a sample of bodily fluid from a 
10 patient and performs an electrochemical analysis of the 
amount of an analyte, for example glucose, in the sample 
that includes a receptacle for receiving a container in 
which disposable test strips are provided, and a mechan- 
ism for reading calibration values calibration values 
15 specific to the disposable test strips that are affixed 

to the container. For example, calibration values can be 
applied to the container in the form of a machine 
readable bar-code, a magnetic stripe, a memory chip or as 
a resonant wire loop. By automatically obtaining 
20 calibration values from the container in which the strips 
are provided, the chances of using the wrong calibration 
information are greatly reduced. 

In addition to calibration values, the 
container may contain additional information readable by 
25 the meter which will enhance the safety of the individual 
using the device. For example, the container may include 
a machine readable expiration date, which would permit 
the meter to either give a warning or to refuse to 
process' a test strip which was beyond its expiration 
30 date. In addition, the container may include information 
about the number of test strips in the container. Since 
any effort to process more strips than were originally 
supplied in the container would in all likelihood result 
in the use of the wrong calibration codes, a warning or 
35 refusal to process the strip would be appropriate in this 
instance as well. 



* WO 97/29847 



PCT/US97/02166 



BRIEF DES CRI PT ION QF THE DR AW INGS 
Fig. 1 shows a cross section of a glucose meter 
in accordance with the invention; 

Fig. 2 shows a top view of a glucose meter in 
5 accordance with the invention; 

Fig. 3 shows one embodiment of a receptacle for 
receiving a container of test strips in accordance with 
the invention; 

Fig. 4 shows one embodiment of a receptacle for 
10 receiving a container of test strips in accordance with 
the invention; 

Fig. 5 shows the functional parts of a meter in 
accordance with the invention schematically; 

Figs 6A - 6B illustrate the operation of 
15 several embodiments of the inventions; and 

Fig. 7 shows a container in accordance with the 

invention. 

DETAILED pgSCRIPTIQN QF THE INVB N T TQN 

20 Figs. 1 and 2 shows a meter in accordance with 

the invention. The meter has a top housing member 1 and 
a bottom housing member 2 . Bottom housing member 2 has a 
receptacle 7 affixed thereto for receiving a container 10 
of test strips. Bottom housing member 2 also has an 

25 opening for receiving batteries to power the meter which 
is sealed in use by battery cover 4. Top housing member 
1 has openings formed therein for a liquid crystal or 
light emitting diode display 3 f and for control buttons 
5. In addition, top housing member 1 and bottom housing 

30 member: 2 taken together form a slot 12 into which a test 
strip is inserted for measurement of glucose. 

Fig. 3 shows a detailed view of one embodiment 
of a receptacle for a test strip container in accordance 
with the present invention. The receptacle 7 is open at 

35 the front end 31 to receive a test strip container and 
has a retractable catch 32 for holding the container in 
position in the receptacle. On one surface of the 



WO 97/29847 



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- 4 - 

receptacle 7 is an opening 33 through which machine- 
readable characters, e.g. a bar code, printed on the 
container can be read. Although the receptacle 7 in Pig. 
3 is shown as a regular shape, it may be desirable to 
make the container and the receptacle of corresponding 
asymmetrical shapes to ensure alignment of the machine- 
readable characters with the opening. 

Fig. 4 shows a cross section of an alternative 
embodiment of the receptacle 7, m this embodiment, a 
line of electrical contacts 41 are arranged to engage 
with a corresponding set of contacts on the container to 
that information stored on a chip built into the 
container can be made. The contacts 41 are in turn 
connected to the meter for processing of the information. 

Fig. 5 shows a functional parts of the glucose 
meter of the invention schematically for purposes of 
understanding the operation of the invention. As shown, 
coded information 50 recorded on a test strip container 
10 disposed within receptacle 7 is functionally connected 
to means 51 for reading the information affixed to the 
container. The means for reading the information must, of 
course, be compatible with the manner in which the 
information 50 is recorded on the container. Thus, for 
example, in the case of information recorded in a bar- 
code format, the means 51 for reading the information 
affixed to the container will be a bar-code reader. For 
a magnetic strip, the means 51 will be a magnetic stripe 
reader. In the case where the information on the 
container is recorded in a memory chip, for example a 
"TOUCH MEMORY" chip manufactured by Dallas Semiconductor 
or other semiconductor device capable of storing 
information for retrieval by a remote device, the means 
51 for reading the information is a microprocessor which 
sends a query to the chip and receives back a signal 
reflecting the stored contents of the chip, in the case 
where the information is stored as a resonating wire 
loop, the resonating frequency of which indicates the 



WO 97/29847 



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- 5 - 

information, the means 51 for reading the information is 
an rf generator and detector which scans across possible 
resonance frequencies and monitors for a resonant 
emission from the wire loop. 
5 The means 51 for reading the information is 

functionally connected to a microprocessor 52 for con- 
trolling the device. When the user depresses the start 
key 5, the microprocessor 52 queries the means 51 for 
reading the information from the container and either 

10 evaluates the sample which has placed in the slot 12, 

evaluates the sample with a warning to the user, or 
refuses to evaluate the sample. If the sample is evalu- 
ated, with or without a warning, the microprocessor 
receives output from the electrodes 53 on the test strip, 

15 applies the calibration factors received from the means 
51 for reading the information from the container, and 
causes the resulting glucose level to be displayed on 
display 3 . 

Pigs. 6 A - E illustrate several variations of 

20 information 50 which can be recorded on a container in 
accordance with the present invention, and the ways in 
which the microprocessor 52 can make use of the recorded 
information. In Fig. 6A, the information 50 recorded on 
the container is simply the calibration values for the 

25 test strips in the container. In this case, the 

microprocessor 52 simply applies the calibration values 
to the raw electrode output arid converts it to a digital 
value, to arrive at a calibrated glucose display. 

In Fig. 6B, the information 50 recorded on the 

30 container includes both the calibration values and the 
number of test strips originally in the container. 
Microprocessor 52 maintains a register 60 in which a 
counter X is stored. The counter X is set to zero 
whenever a new container is loaded into the receptacle 7, 

35 and is incremented each time a test strip is evaluated. 
Each time the meter is used, the microprocessor 52 
compares the value of X stored in register 60 to the 



WO 97/29847 



PCT/US97/02166 



- 6 



number of test strips originally in the container. If the 
X is less than or equal to the original number of test 
strips, the microprocessor operates in a normal manner 
and a calibrated glucose value is displayed. If x is 
greater than the original number of strips, the 
microprocessor generates an error signal. This error 
signal may cause the meter to provide a result together 
with a warning that the result is suspect, or may cause 
the microprocessor to refuse to display a result at all. 

Fig. 6C shows an embodiment in which the 
information 50 recorded on the container includes cali- 
bration values and an expiration or manufacturing date. 
In this case, the microprocessor 52 includes a clock 61 
which is set initially by the user or by the factory and 
which is incremented automatically by the microprocessor 
to maintain the date accurately. The microprocessor 52 
compares the expiration date recorded on the container to 
the clock, and acts in one of three ways depending on the 
results of this comparison. As shown, when the actual 
date is before the expiration date by some pre -determined 
threshold amount, for example 10 days, the microprocessor 
52 simply generates a calibrated glucose display. When 
the actual date is closer to the expiration date than the 
predetermined threshold, and perhaps for several days 
after the expiration date, the microprocessor 52 
generates a low level error signal which causes the meter 
to display a calibrated glucose reading along with a 
warning. Thereafter, the microprocessor generates a high 
level error signal which results in the meter refusing to 
provide a reading. 

A variation on the embodiment shown in Fig. 6C 
would use the clock to also monitor the time since the 
container was placed in the receptacle, in this case, as 
shown in Pig. 6D, the microprocessor would also include a 
storage register 64 in which the date on which a new 
container is placed in the receptacle is stored, in 
addition to checking the expiration date, the 



WO 97/29847 



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microprocessor 52 would also compare the current date to 
the date stored in register 62 . If this difference were 
greater than a predetermined threshold level, the meter 
would generate a warning and/or refuse to operate. This 
5 embodiment is particularly useful where the shelf life of 
the test strips in the sealed container is longer than 
the shelf life after the container has been opened for 
first use. In addition, by generating a warning when a 
container of strips is lasting longer than expected, the 

10 meter could provide a reminder that tests need to be 
performed on a regular basis; 

Fig. 6E shows a further embodiment of the 
invention in which the information 50 stored on the con- 
tainer includes both calibration values and the identifi- 

15 cation of the analyte for which the strip is intended. 

This embodiment is particularly useful where disposable 
test strips for several analytes, for example glucose and 
ketones can be evaluated in the same meter but require 
different processing of the raw data to obtain optimum 

20 results. 

The various types of information and the 
resulting processing options depicted in the Figs 6A-6E 
can be used in any combination. Thus, for example, a 
container in accordance with the invention might include 

25 calibration values, analyte ID and expiration date; 

calibration values, number of strips and expiration date; 
number of strips and expiration date; or any other 
combination of information types. 

While the checks described above will greatly 

30 reduce the chances of using incorrect calibration values 
or out-of-date test strips, it may also be advantageous 
to provide the ability to deactivate the information 
stored on the container so that it cannot be used beyond 
a certain point. For example, deactivation of the 

35 container after a number of tests had been run equal to 
the number of strips into the container would eliminate 
the possibility that an individual might place additional 



WO 97/29847 



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- 8 - 

test strips which did not match the calibration values of 
the container. 

The mechanism of deactivation, like the 
mechanism for reading the information depends on the 
manner in which the information is stored. For example, 
in the case of a bar-code, the information might be 
rendered unreadable by exposing a photosensitive region 
to light which causes a color change for example to alter 
the bar code to an unreadable pattern. For an emitter 
loop, a fusible link can be included which is fused by a 
pulse of an appropriate frequency, render the shorting 
the emitter loop and rendering it inoperative. In the 
case of a programmable memory chip, deactivation might be 
accomplished by writing over a portion of the stored 
information, or by inducing a magnetic field near the 
chip of sufficient magnitude to render the stored 
information meaningless, and therefore unreadable. The 
generation of a magnetic field will also render a 
magnetic stripe inoperative. 

A further aspect of the present invention is 
the containers which can be used in the meter according 
to the invention . As shown in Fig. 7, such a container 
generally comprises a sealable body member 70 for 
receiving at least one glucose test strip; and machine- 
readable means 71 for storing information specific to 
disposable test strips provided in the container. As 
will be apparent from the foregoing discussion of the 
alternative reading means which can be included in a 
meter according to the invention, the machine readable 
means 71 can be a bar- code, a memory chip, or a resonant 
wire loop, or any other form of machine readable storage 
which can be adapted for use in a small device of the 
type claimed. 



WO 97/29847 



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- 9 - 
Claims 



1 1. A test meter of the type which receives a 

2 disposable test strip and a sample of bodily fluid from a 

3 patient and performs an electrochemical analysis of the 

4 amount of an analyte in the sample, characterized in that 

5 the meter comprises 

6 (a) a receptacle for receiving a container in 

7 which disposable test strips are provided, said container 

8 having affixed thereto information specific to the 

9 disposable test strips provided in the container in a 

10 form readable by the test meter; 

11 (b) means for reading the information affixed 

12 to the container. 

1 2. The test meter according to claim 1, 

2 wherein the means for reading the information comprises a 

3 bar-code reader. 

1 3. The test meter according to claim 1, 

2 wherein the means for reading the information comprises a 

3 radio frequency emitter and receiver effective to 

4 evaluate a resonant wire loop used to store information 

5 specific to the test strips in the container. 

1 4. The test meter according to claim 1, 

2 wherein the means for reading the information comprises a 

3 microprocessor for retrieving information from a memory 

4 chip used to store information specific to the test 

5 strips in the container. 

1 5 . The meter according to any of claims 1 to 

2 4, wherein the information specific to the disposable 

3 test strip includes calibration values for the disposable 

4 test strips, and wherein the meter further comprises 

5 means for applying the calibration values to a raw data 



WO 97/29847 



PCTAJS97/02166 



- 10 - 

6 value to produce a calibrated value for the amount of 

7 analyte. 

1 6. The meter according to claim 5, further 

2 comprising means for displaying the calibrated value for 

3 the amount of analyte. 



7. The meter according to any of claims l to 
6, wherein the information specific to the disposable 
test strip includes the number of test strips originally 
provided in the container, and the meter further 

5 comprisee a data storage register for storing a value 

6 equal to the number of test strips used from the 

7 container and means for generating an error signal 

8 whenever the value stored in the data storage register 

9 exceed the number of test strips originally provided in 
10 the container. 

1 8. The meter according to any of claims 1 to 

2 7, wherein the information specific to the disposable 

3 test strip includes the expiration date of test strips 

4 provided in the container, and the meter further 

5 comprises a data storage register for storing the current 

6 date and means for generating an error signal whenever 

7 the value stored in the data storage register is later 

8 than the expiration date of the test strips provided in 

9 the container. 



2 



8 



9, The meter according to claim 8, wherein 
the means for generating an error signal generates a low 
level error signal which causes the meter to display a 
calibrated result and a warning when the date stored in 
the data register is within some predetermined number of 
days before or after the expiration date, and a high 
level error signal which causes the meter to refuse to 
display a calibrated result when the date stored in the 



WO 97/29847 



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- 11 - 

9 data register is more than the predetermined number of 

10 days after the expiration date. 

1 10. The meter according to any of claims 1 to 

2 9, further comprising means for rendering the information 

3 affixed to the container unreadable when a predetermined 

4 set of conditions is met. 

1 11. The meter according to any of claims 1 to 

2 10 r wherein the analyte is glucose. 

1 12. A container for disposable test strips for 

2 use in a test meter of the type which receives a 

3 disposable test strip and a sample of bodily fluid from a 

4 patient and performs an electrochemical analysis of the 

5 amount of an analyte in the sample, comprising 

6 (a) a sealable body member for receiving at 

7 least one test strip; and 

8 (b) machine -readable means for storing 

9 information specific to disposable test strips provided 
10 in the container. 

1 13. The container according to claim 12, 

2 wherein the machine -readable means is a bar-code. 

1 14 . The container according to claim 12 , 

2 wherein the machine -readable means is a memory chip. 

1 15. The container according to claim 12, 

2 wherein the machine -readable means is a resonant wire 

3 loop. 

1 16. The container according to claim 12, 

2 wherein the machine -readable means is a magnetic stripe. 

1 17. The container according to any of claim 12 

2 to 16, further comprising means for rendering the 



WO 97/29847 



PCT/US97/02I66 



- 12 - 

3 machine-readable means unreadable in response to an 

4 externally applied signal. 

1 18. The container according to any of claims 

2 12 to 17, wherein the information specific to the test 

3 strips includes calibration values for the test strips. 

1 19. The container according to any of claims 

2 12 to 18, wherein the information specific to the test 

3 strips includes the number of test strips originally 

4 provided in the container. 



1 20. The container according to any of claims 

2 12 to 19, wherein the information specific to the test 
strips includes the expiration date of the test strips 

4 provided in the container. 



3 



WO 97/29847 



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FIG. 2 

SUBSTITUTE SHEET (RULE 26) 



WO 97/79847 



PCT/US97/0216* 



2/6 




FIG. 4 

SUBSTITUTE SHEET (RULE 26) 



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PCT/US97/02166 



3/6 



5 




/ 




7 






CALIBRATION 




VALUES 


50 









i 




53 







FIG. 5 



52 



CALIBRATED 
OUTPUT 



RAW DATA 



53 



FIG 6A 



SUBSTITUTE SHEET (RULE 26) 



WO 97/29847 



PCT/TJS97/02166 



4/6 




CALIBRATION 

VALUES 

NO. OF STRIPS 



CALIBRATED 
OUTPUT 




IF X < NO. 
OF STRIPS 



IFX>NO. 
OF STRIPS 



RAW 
DATA 




ERROR 
SIGNAL 



53 



FIG. 6B 




CALIBRATION 
VALUES 
EXPIRATION 
DATE 




CALIBRATED 
OUTPUT 



IF DATE <EXR 
DATE -10 




IF EXP. DATE 
-9<DATE< 
EXP. DATE +9 



IF DATE > EXP. 
DATE +10 



LOW 
LEVEL 
ERROR 
SIGNAL 



HIGH 
LEVEL 
ERROR 
SIGNAL 



FIG. 6C 



SUBSTITUTE SHEET (RIM 26) 



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PCT/US97/02166 



5/6 




CALIBRATION 
VALUES 
EXPIRATION 
DATE 




52 





CALIBRATED 
OUTPUT 

IF DATE < EXP 
DATE -10 AND 
61< 64 + THRESHOLD 



IF EXP DATE -9 < DATE < 
EXP DATE +9 OR 
61 > 64 + L0W 
THRESHOLD LEVEL 
" *" ERROR 

SIGNAL 





RAW 




DATA 


53 







IF DATE > EXP. 
DATE +10 



HIGH 
LEVEL 
ERROR 
SIGNAL 



FIG. 6D 




CALIBRATION 

VALUES 

ANALYTE 



52 



CALIBRATED 
OUTPUT FOR 
CORRECT 
ANALYTE 



RAW 
DATA 




FIG. 6E 

SUBSTITUTE SHEET (RULE 26) 



WO 97/29847 



PCTAUS97/02166 




SUBSTITUTE SHEET (RULE 26) 



INTERNATIONAL SEARCH REPORT 



hnu-.^l Application No 

PCT/US 97/92166 



A. CLASSIFICATION OF SUBJECT MATTER 

PC 6 B91L11/O0 601M33/487 B01L9/G9 



According to jntematijanaj Paten! Classification (IPC) or to both national cUafiatbon and IPC 



B. FIELDS SEARCHED 



Minimum documentation searched (classification system followed by classification symbols) 

IPC 6 BOIL 



Documentation searched other than nummura documentation to the extent that such documents are included in the fields searched 



Electronic data base consulted during (he international search (name of data base and, where practical, search terms used) 



C. DOCUMENTS CONSIDERED TO BE RELEVANT 



Category * Citation of document, with indication, where appropriate, of the relevant passages 



Relevant to claim No. 



US 5 489 414 A (SCHREIBER JOERG ET AL) 6 
February 1996 

see column 2, line 15 - line 26 
see column 4, line 58 - line 60 
see column 4, line 65 - column 5, line 12 

US 5 277 870 A (FULLER) 11 January 1994 

see column 1, line 29 - line 33 

see column 1, line 49 - line 53 

see column 1, line 63 - column 2, line 23 

US 4 303 887 A (HILL JEREMY R ET AL) 1 
December 1981 

see page 1, line 58 - page 2, line 20 
see column 12 f line 25 - line 28; figure 1 

-/-- 



1-4 



m 



Further t 



i are listed in the 



of box C. 



|X j Patent family members are listed in a 



* Special categories of cited d oc um e nts : 

* A* document defining the general state of the ait which is not 

considered to be of particular relevance 
*E* earlier document but published on or after the mtcrnahonal 
filing date 

*L* tit cumcnt which may throw doubts on priority daimfx) or 
which is cited to e s ta blish the publication date of another 
citation or other special reason (as specified) 

'O* document referring to an oral disclosure, use, exhibition or 
other means 

*P* document published prior to the tote manorial filing dale but 
later than the priority date cla i m e d 



T later document published after the international filing date 
or priority date and not in conflict with the application but 
cited to understand the principle or theory underlying me 



-X* document of particular relevance; the daimed invention 
cannot be cui uidcr cd novd or cannot be considered to 
involve an inventive step when the document is taken alone 

*Y* document of particular relevance; the daimed invention 
cannot be considered to involve an inventive step when the 
document is combined with one or more other such docu- 
ments, such coci^naticm bocg obvious to a pem*i dolled 
in the art. 

'A* document member of the same patent family 



Date of the actual cotnptcnon of the international search 



19 June 1997 



Date of mailing of the 



international search report 



Name and mailing address of the ISA 

European Patent Office, P.B. SSI 8 Patcntiaan 2 
NL - 22SO HV Rijswijt 
Tct ( + 31-70) 340.2040, Tx. 31 651 epo m. 
Fax (-> 31-70) 340-3016 



Hocquet, A 



Food PCT/OA/BO (m 



I i* act} (July IW) 



page 1 of 2 



INTERNATIONAL SEARCH REPORT 



Intern* — .•*) Application No 

PCT/US 97/02166 



^Continuation) DOCUMENTS CONSIDERED TO BE RELEVANT 



Category ' Citation of document, wift indication, where appropriate, of the relevant praps 



EP 0 649 393 A (BQEHRINGER MANNHEIM GMBH) 

I March 1995 

see column 4, line 23 - line 31 

US 4 852 025 A (HERPICHBOEHM BERND) 25 
July 1989 

see coluim 2, line 7 - line 47 

see column 3, line 50 - line 60 

see column 12, line 25 - line 32; figure 6 

WO 94 10558 A (EN VI ROM ED PLC ; FRIED LANDER 
URI (GB); HIGGINS IRVING JOHN (GB); COS) 

II May 1994 

see page 1, line 1 - line 6 

see page 2, paragraph 4 

see page 4, paragraph 2 - paragraph 3 

see page 6 

CH 677 149 A (DISETRONIC AG) 15 April 1991 

see column 2, line 25 - coluim 3, line 58 
see column 4, line 15 - line 19 
see column 4, line 49 - line 53 

EP 0 567 067 A (FUJI PHOTO FILM CO LTD) 27 
October 1993 

see column 1, line 1 - line 13 
see coluim 2, line 15 - line 20 
see column 9, line 1 - line 40 
see column 14, line 41 - line 52 
see column 22, line 8 - line 17 



Relevant to claim No. 



1-5 

12 

1,5 



8-10,17, 
20 

1.12 



12-16, 
18,20 



Term PCT/tSA/2IB (cmriJmiatiOA of fax* (JWy 1993) 



page 2 of 2 



INTERNATIONAL SEARCH REPORT 

Information on patent family members 



I»tenu.-.aa1 Application No 

PCT/US 97/D2166 



Patent document 
cited in search report 



Publication 
date 



Publication 





member (s) 


1 due 


DE 


4313252 A 


27-10-94 


DE 


4328816 A 


02-03-95 


EP 


0622119 A 


02-11-94 


EP 


0622626 A 


02-11-94 


OP 


6308115 A 


04-11-94 


JP 


6313765 A 


08-11-94 



US 5489414 A 



06-02-96 



US 5277870 A 11-01-94 US 5174963 A 29-12-92 



US 4303887 A 01-12-81 



CA 


1153580 A 


13-09-83 


CA 


1152772 A 


30-08-83 


DE 


3040233 A 


17-09-81 


FR 


2468945 A 


08-05-81 


FR 


2476350 A 


21-08-81 


GB 


2069702 A,B 


26-08-81 


G6 


2077927 A,B 


23-12-81 


OP 56079242 A 


29-06-81 



EP 0640393 A 01-03-95 DE 4328815 A 02-03-95 

OP 7069360 A 14-03-95 
US 5505308 A 09-04-96 



US 4852025 A 25-07-89 DE 3617161 A 26-11-87 

EP 0247439 A 02-12-87 

HK 46393 A 21-65-93 

OP 1808984 C 10-12-93 

OP 5016745 B 05-03-93 

OP 62285040 A 10-12-87 



WO 9410558 


A 


11-05-94 


AU 5374594 A 
EP 0667956 A 


24-05-94 
23-08-95 


CH 677149 


A 


15-04-91 


WO 9100998 A 
DE 59005357 D 
EP 0436679 A 


24-01-91 
19-05-94 
17-07-91 


EP 0567067 


A 


27-10-93 


OP 6213903 A 
US 5538688 A 


05-08-94 
23-07-96 



Ftavm PCT.1SA.aiO (p«af* family man) (to* WJ) 



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